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Assessing the Impact on Health of Pharmacovigilance Activities: Example of Four Safety Signals

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Abstract

Introduction

The impact of pharmacovigilance activities on public health remains under-investigated, and measuring the impact on health of pharmacovigilance activities for a specific safety signal is challenging.

Objective

To gain more insight into the methodological challenges and the data required, we assessed the impact of pharmacovigilance on public health for four identified product-specific safety signals using publicly available data in the Netherlands. The assessment was on the impact of the intertwined and complementary steps of the pharmacovigilance pathways.

Methods

The impact of pharmacovigilance on public health was assessed using the assessment support tool and ‘open data’ from the Netherlands for four different types of pharmacovigilance safety signals: (1) off-label use of cyproterone acetate/ethinyloestradiol (CPA/EE) and thrombotic risk after pharmacovigilance measures after 2014; (2) pergolide and the risk of cardiac valvulopathy after pharmacovigilance activities in 2003; (3) proton pump inhibitors and the risk of hypomagnesaemia after pharmacovigilance activities in 2011; (4) rosiglitazone withdrawal from the market because of cardiovascular effects in 2010.

Results

For the signals on CPA/EE and pergolide, a crude estimation of the impact could be made with varying degrees of assumptions based on the risk described in the literature and utilisation data.

Conclusion

This article highlights the methodological challenges and the data required to assess the impact of product-specific safety signals. A structured assessment support tool can be used as a guide for the necessary data elements and steps needed for the measurement or estimation of impact of pharmacovigilance activities on public health, provided that the appropriate data are available.

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Authors and Affiliations

  1. Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, ’s-Hertogenbosch, The Netherlands

    Florence van Hunsel, Laura Peters & Agnes Kant

  2. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht, Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands

    Laura Peters & Helga Gardarsdottir

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  1. Florence van Hunsel
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Correspondence to Florence van Hunsel.

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Florence van Hunsel, Laura Peters, Helga Gardarsdottir, and Agnes Kant have no conflicts of interest that are directly relevant to the content of this study.

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Publicly available data were used for this research. The data used during the current study are available from the corresponding author on reasonable request.

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FH, LP, HG, and AK contributed to the article. LP eters performed the assessments of the impact, with input from the other authors. FH wrote the first draft of the manuscript with input from all other authors. All authors contributed to manuscript revision and read and approved the submitted version.

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van Hunsel, F., Peters, L., Gardarsdottir, H. et al. Assessing the Impact on Health of Pharmacovigilance Activities: Example of Four Safety Signals. Drug Saf 44, 589–600 (2021). https://doi.org/10.1007/s40264-021-01047-1

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